Description
Chlorambucil Film-Coated Tablets (2 mg / 5 mg)
Healthy Inc is a specialized global supplier and exporter of advanced oncology, hematology, and targeted high-containment cytotoxic therapeutics. We provide ultra-high-purity, kinetically stabilized Chlorambucil Tablets (2 mg / 5 mg), manufactured in WHO–GMP certified, strictly segregated maximum-containment (OEB 5) oncology oral solid dosage facilities. This “Aromatic Nitrogen Mustard Alkylating Agent” is a highly strategic export to hematology networks, cancer institutes, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for Chronic Lymphocytic Leukemia (CLL) and Indolent Non-Hodgkin Lymphomas.
Product Overview
This highly advanced formulation operates as a persistent, DNA-targeting saboteur. While it is a member of the nitrogen mustard family, its aromatic structure makes it slower-acting and less toxic than other alkylating agents, allowing for the precise, long-term suppression of malignant white blood cells.
The “Slow-Release Alkylator & Lymphocyte Specialist”:
- Mechanism 1 (DNA Cross-Linking): Chlorambucil is a bifunctional alkylating agent. It physically attaches alkyl groups to the DNA bases, specifically at the N7 position of guanine. By forming covalent “bridges” or cross-links between the two strands of the DNA double helix, it prevents the strands from separating. When the cancer cell attempts to divide, the DNA shatters, triggering apoptosis.
- Mechanism 2 (Selective Lymphoid Targeting): Chlorambucil shows a high degree of selectivity for lymphoid tissues. It aggressively targets and depletes malignant B-lymphocytes while sparing many other rapidly dividing cells, making it the ideal “Gentle Chemotherapy” for elderly patients with chronic leukemia who cannot tolerate aggressive IV regimens.
- Mechanism 3 (Metabolic Activation): It is partially metabolized in the liver to phenylacetic acid mustard, which also possesses potent alkylating activity, extending the drug’s therapeutic window and ensuring sustained suppression of the malignant cell population.
Technical & Logistics Specifications
| HS Code | 3004.90.99 (Medicaments containing other active substances – Oncology/Antineoplastics) |
| CAS Number | 305-03-3 (Chlorambucil) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Storage (CRITICAL) | Cold Chain Mandatory: Store at 2°C to 8°C (Refrigerate). Chlorambucil is chemically unstable at room temperature; heat exposure causes rapid degradation into toxic byproducts. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- OEB 5 High-Containment & Mutagenic Safety (CRITICAL COMPLIANCE): Chlorambucil is a potent carcinogen and mutagen. Our oncology suites utilize Isolator Technology and Negative Pressure Cascades to prevent any API escape. We provide global buyers with a product manufactured under the highest safety standards, ensuring 100% purity and absolute liability protection for the supply chain.
Therapeutic Indications
- Chronic Lymphocytic Leukemia (CLL): First-line and maintenance treatment for CLL.
- Non-Hodgkin Lymphoma (NHL): Management of follicular lymphoma and other low-grade indolent lymphomas.
- Waldenström’s Macroglobulinemia: Primary treatment for this rare B-cell malignancy.
- Hodgkin’s Disease: Palliative treatment in advanced stages.
Dosage & Administration
- Standard Adult Dosing: Highly individualized; typically 0.1 mg/kg to 0.2 mg/kg daily for 3 to 6 weeks, or intermittent pulse doses.
- The “Do Not Crush” Mandate (CRITICAL): Tablets MUST be swallowed whole. Crushing or breaking the tablet creates a cytotoxic dust hazard for the caregiver and patient.
- Empty Stomach Rule: Best taken on an empty stomach to ensure consistent and rapid absorption.
Safety Warnings (CRITICAL):
- BLACK BOX WARNING (Myelosuppression): Causes severe, dose-dependent bone marrow suppression. Frequent CBC monitoring is mandatory.
- Carcinogenicity: Long-term use is associated with a significantly increased risk of secondary acute leukemia.
- Teratogenicity: Highly toxic to the fetus; must never be used during pregnancy.
- Seizure Risk: High doses in children (nephrotic syndrome) have been linked to seizures.
Global Export & Contract Manufacturing Services
Healthy Inc is a premier Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-containment Oncology drugs. Whether you are a Government Tender Supplier for national cancer institutes in Africa or a B2B Pharma Marketplace partner in Latin America, we ensure secure, cold-chain-compliant, WHO-GMP delivery.








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